Prescription drug · NDA
Twyneo (Tretinoin and benzoyl peroxide) NDC 0299-5945
Tretinoin 1 mg/g; Benzoyl peroxide 30 mg/g · Cream · Topical · Galderma Laboratories, L.P.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0299-5945-00 | 0029959450000299594500 | 6 g in 1 TUBE (0299-5945-00)Marketed from Mar 15, 2022 · Sample package | |
| 0299-5945-05 | 0029959450500299594505 | 30 g in 1 BOTTLE, PUMP (0299-5945-05)Marketed from Jul 11, 2023 · Sample package | |
| 0299-5945-30 | 0029959453000299594530 | 1 BOTTLE, PUMP in 1 BOX (0299-5945-30) / 30 g in 1 BOTTLE, PUMPMarketed from Mar 15, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Twyneo
- Generic name (nonproprietary)
- tretinoin and benzoyl peroxide
- Active ingredients
- Tretinoin — 1 mg/gBenzoyl peroxide — 30 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Galderma Laboratories, L.P.NDC labeler code 0299
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214902
- Marketing start
- Marketing end
- Other FDA classes
- Retinoids (Chemical structure)
- Identifiers
- Product ID 0299-5945_c8da4970-d262-4f55-a092-0a469789eb1fSPL ID c8da4970-d262-4f55-a092-0a469789eb1fSPL set ID 27208dff-e376-4c18-b56e-0a260f685a39RxCUI 2565807, 2565812UNII 5688UTC01R, W9WZN9A0GM
- Pharmacologic class
- Retinoid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400299594500followed by a unit qualifier and the quantityPackage 00299-5945-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
TWYNEO is indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. TWYNEO is a combination tretinoin, a retinoid, and benzoyl peroxide indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0299-5945
- What is NDC 0299-5945?
- 0299-5945 is the product NDC for Twyneo, Tretinoin 1 mg/g; Benzoyl peroxide 30 mg/g cream, listed with the FDA by Galderma Laboratories, L.P.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Twyneo (Tretinoin and benzoyl peroxide).
- What is the active ingredient?
- Tretinoin, Benzoyl peroxide.
- Who is the labeler?
- Galderma Laboratories, L.P., NDC labeler code 0299. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Twyneo?
- 1 other product NDC are listed under this name. See all Twyneo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Twyneo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Twyneobenzoyl peroxide and tretinoin | Benzoyl peroxide 30 mg/g; Tretinoin 1 mg/g | CreamTopical | Mayne Pharma Commercial LLC | 51862-771 | 51862-0771-30 |
Other NDCs under NDA 214902
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Twyneobenzoyl peroxide and tretinoin | Benzoyl peroxide 30 mg/g; Tretinoin 1 mg/g | CreamTopical | Mayne Pharma Commercial LLC | 51862-771 |